Product Recalls in 2017

FDA Drug Class I Terminated

Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6145-10

April 20, 2017 C. O. Truxton unknown units

FDA Drug Class II Terminated

Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10

April 20, 2017 C. O. Truxton unknown units

FDA Drug Class II Terminated

Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10

April 20, 2017 C. O. Truxton unknown units

FDA Drug Class II Terminated

Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 B

April 19, 2017 Qualgen 5,260 pellets. units

FDA Drug Class II Terminated

Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park

April 19, 2017 Qualgen 4,468 pellets. units

FDA Drug Class II Terminated

Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 1484

April 19, 2017 Qualgen 4,883 pellets. units

NHTSA Ongoing

Loose Ball Joints may cause Loss of Steering

April 19, 2017 Rosenbauer Motors 34 units

FDA Food Class I Terminated

SAMIRA'S HOMEMADE Muhammara Roasted Red Pepper Dip with Walnuts & Pomegranate Molasses, All Natural, NET WT. 8 OZ (229G) Keep Refrigerated

April 19, 2017 Samiira's Homemade 709 units units

NHTSA Ongoing

Roof may Crush in a Rollover/FMVSS 220

April 19, 2017 CORP. MICRO BIRD, INC. 602 units

FDA Drug Class II Terminated

Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 1484

April 19, 2017 Qualgen 1,153 pellets. units

FDA Drug Class II Terminated

Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Br

April 19, 2017 Qualgen 4,815 pellets. units

NHTSA Ongoing

Fan Support Bearing Failure

April 19, 2017 CUMMINS, INC. 227 units

FDA Drug Class II Terminated

Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844

April 19, 2017 Qualgen 6,227 pellets units

FDA Drug Class II Terminated

Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40

April 19, 2017 Gentell, Inc 65 gallons units

FDA Drug Class II Terminated

Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 B

April 19, 2017 Qualgen 6,361 pellets. units

FDA Drug Class II Terminated

Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844

April 19, 2017 Qualgen 1,666 pellets. units

FDA Drug Class II Terminated

PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 2 vials units

FDA Drug Class II Terminated

PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 40 vials units

FDA Drug Class II Terminated

PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 9 vials total (3/10mL vials and 6/50mL vials) units

FDA Drug Class I Terminated

TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages, Made in USA Distributed by American Health Supplements, Chicago, Illinois --

April 18, 2017 Organic Herbal Supply

FDA Drug Class I Terminated

ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 6804

April 18, 2017 Organic Herbal Supply

FDA Drug Class I Terminated

LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY --- UPC Code 680474228904

April 18, 2017 Organic Herbal Supply

FDA Drug Class II Terminated

TRI MIX 20/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 2 vials units

FDA Drug Class II Terminated

HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 72 vials units

FDA Drug Class II Terminated

FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 20 vials units

FDA Drug Class II Terminated

TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 2 vials units

FDA Food Class II Terminated

RALEY'S MUESLI ALMOND CRUNCH MUESLI CEREAL; 12 oz. box - foil bag inside paper box. UPC: 46567-02263; Product Distributed by Raley's, West Sacramento, CA; Product of Switzerland

April 18, 2017 Raley's 21,180 Units units

FDA Drug Class II Terminated

PGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL, Rx only, packaged in a 5 mL, 10mL, and 15 mL Glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 5 vials total (2/5 mL vials, 1/10mL vial, and 2/15mL vials) units

FDA Drug Class II Terminated

GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 240 mL units

FDA Drug Class II Terminated

PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 4 vials units

FDA Drug Class II Terminated

TRI MIX 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 25 vials units

FDA Drug Class II Terminated

SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 91 vials units

FDA Drug Class II Terminated

PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass; Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 1 vial units

FDA Drug Class I Terminated

ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 852675999

April 18, 2017 Organic Herbal Supply

FDA Drug Class II Terminated

VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 6/1mL vials units

FDA Drug Class II Terminated

PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 3 vials units

FDA Drug Class II Terminated

FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 3 vials total (2/5mL vials and 1/10mL) units

FDA Drug Class II Terminated

VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 10 mL units

FDA Drug Class II Terminated

METHYL-B12 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 25 vials units

FDA Drug Class II Terminated

PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 4 vials units

FDA Drug Class II Terminated

PYRIDOXAL-5-PHOS 5ML MDV 50MG/ML INJ, 50mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 3 vials units

FDA Drug Class II Terminated

QUAD MIX 1/30/0.5/0.1 5ML MDV MCG/MG/MG/MG/ML INJ, Injection, 1mcg/30mg/0.5mg/0.15mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 2 vials units

FDA Drug Class II Terminated

PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 1 vial units

FDA Drug Class II Terminated

SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 75 mL units

FDA Drug Class II Terminated

CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 1 vial units

FDA Drug Class II Terminated

PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 2 vials units

FDA Drug Class II Terminated

ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 60 mL total units

FDA Food Class II Terminated

RALEY'S MUESLI CHOCOLATE CURLCRUNCH CEREAL; 12 oz. box - foil bag inside paper box. UPC: 46567-02266;Product Distributed by Raley's, West Sacramento, CA;Product of Switzerland

April 18, 2017 Raley's 15,252 units units

FDA Drug Class II Terminated

HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 50 vials units

FDA Drug Class I Terminated

BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 68047

April 18, 2017 Organic Herbal Supply